Antisera, All Leptospira Spp.

Device Code: 3283

Product Code(s): GRX

Device Classification Information

Device Type ID3283
Device NameAntisera, All Leptospira Spp.
Regulation DescriptionLeptospira Spp. Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3350 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGRX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3283
DeviceAntisera, All Leptospira Spp.
Product CodeGRX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionLeptospira Spp. Serological Reagents.
CFR Regulation Number866.3350 [🔎]
TPLC Last Update: 2019-04-02 20:27:02

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